Ingenol mebutate, which is commonly known as milkweed is indicated for the cutaneous treatment of non-hyperkeratotic, non‑hypertrophic actinic keratosis in adults.  The health authority of Ireland has cautioned patients and health care professionals on the use of this product in patients having history of skin cancer.

It was reported in a randomized study results in the year 2017, the product information for Ingenol mebutate was updated to reflect the potential for development of benign skin tumours (keratoacanthoma). Additionally, an increased incidence of squamous cell carcinoma was observed in the preliminary results of an ongoing randomised study. A meta-analysis of four randomized, double-blind, vehicle-controlled studies of the related ester, Ingenol disoxate, found an increased incidence of skin cancer at 14 months in those treated with ingenol disoxate.

The Irish health authority advised patients to be vigilant for any skin lesions and to inform their doctor immediately for any suspicion of occurrences. ^[1]

Currently, European medicines agency (EMA) is monitoring this alert in which the Pharmacovigilance risk assessment committee (PRAC) is reviewing data on the risk of skin cancer associated with Ingenol mebutate.

EMA has recommended the patients to stop using ingenol mebutate during this PRAC review period as there is concern about a possible link between the use of this drug and the development of skin cancer. Therefore, PRAC recommended to suspend the medicine’s marketing authorization as a precaution and noted that alternative treatments are available.

Health-care professionals should stop prescribing ingenol mebutate, consider different treatment options, and advise patients to be vigilant for any developing skin lesions and to seek medical advice promptly should any occur. ^[2]

References:

[1] Drug Safety Newsletter, HPRA, December 2019 (www.hpra.ie)

[2] EMA, 17 January 2020 (www.ema.europa.eu)